• Reviewed and approved product labeling, artwork, advertising, and promotional materials to ensure compliance with applicable regulatory requirements and filings.• Monitored global regulatory and labeling requirements and advised on necessary updates.• Assisted in label development and conducted compliance reviews prior to release.• Performed gap analysis across multiple products and projects to identify areas for improvement.• Utilized eCTDXpress for US submissions and managed global product listings, facility registrations, and licenses.• Created, reviewed, and approved NDA, ANDA, and stability protocols, ensuring they met regulatory standards.• Submitted labeling changes and coordinated with the Regulatory Affairs team for FDA submissions.• Prepared and submitted applications for new drug approvals in compliance with US FDA standards and Regulatory Guidance Checklists.• Maintained expertise in regulatory requirements to support product manufacturing and post-approval changes.• Worked with clients to develop regulatory strategies for clinical trials and IND submissions.• Supported QA/Regulatory personnel with preparing and submitting data to FDA, Health Canada, EU, and other regulatory bodies, Kept up-to-date with regulatory data requirements, SOPs, and industry best practices.• Proficient in Microsoft Office tools, Adobe, SharePoint, Trackwise, and eCTD.• Supported FDA 510(k) submissions and OTC medical device approvals, including compliance for Class 2 Medical Devices.• Provided guidance and support for all labeling activities, including managing the GUDID and GTIN databases.• Deep understanding of global medical device regulations, including FDA 21 CFR Part 801, European MDR/IVDR, and other relevant standards.• Familiarity with ISO standards related to labeling, ISO 15223-1 and ISO 13485, and knowledge of labeling requirements across major markets, including the US, EU, and Canada and additional regions